Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Sunitinib
Drug ID BADD_D02100
Description Sunitinib is a small-molecule multi-targeted receptor tyrosine kinase (RTK) inhibitor. On January 26, 2006, the agent was formally approved by the US FDA for the indications of treating renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST). For these purposes, sunitinib is generally available as an orally administered formulation. Sunitinib inhibits cellular signaling by targeting multiple RTKs. These include all platelet-derived growth factor receptors (PDGF-R) and vascular endothelial growth factor receptors (VEGF-R). Sunitinib also inhibits KIT (CD117), the RTK that drives the majority of GISTs. In addition, sunitinib inhibits other RTKs including RET, CSF-1R, and flt3.
Indications and Usage For the treatment of advanced renal cell carcinoma as well as the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
Marketing Status approved; investigational
ATC Code L01EX01
DrugBank ID DB01268
KEGG ID D08552
MeSH ID D000077210
PubChem ID 5329102
TTD Drug ID D0R0MW
NDC Product Code Not Available
UNII V99T50803M
Synonyms Sunitinib | 5-(5-Fluoro-2-oxo-1,2-dihydroindolylidenemethyl)-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide | Sunitinib Malate | Sutent | SU 11248 | SU011248 | SU 011248 | SU-011248 | SU11248 | SU-11248
Chemical Information
Molecular Formula C22H27FN4O2
CAS Registry Number 557795-19-4
SMILES CCN(CC)CCNC(=O)C1=C(NC(=C1C)C=C2C3=C(C=CC(=C3)F)NC2=O)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Upper-airway cough syndrome22.12.03.0360.000246%
Skin sensitisation23.03.03.052; 10.02.01.0380.000302%Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.000839%
Functional gastrointestinal disorder07.11.01.0160.000168%Not Available
Lower urinary tract symptoms20.02.02.0230.000112%Not Available
Peripheral artery thrombosis24.01.02.0100.000112%Not Available
Eye ulcer06.08.03.0180.000112%Not Available
Autoimmune haemolytic anaemia10.04.01.005; 01.06.01.0040.000112%Not Available
Candida infection11.03.03.021--
Faeces soft07.01.03.0080.000470%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.003078%
Anal incontinence17.05.01.021; 07.01.06.0290.000224%
Liver function test increased13.03.04.031--Not Available
Anal ulcer07.04.01.0010.000224%
Blood blister23.03.01.028; 12.01.06.0130.000414%Not Available
Bone cancer16.29.02.002; 15.09.03.0120.000817%Not Available
Carcinoid syndrome16.32.02.004; 05.08.02.0050.000112%Not Available
Cardiac failure chronic02.05.01.0090.000112%Not Available
Cholangitis acute09.02.01.0060.000112%Not Available
Chronic gastritis07.08.02.005; 11.07.01.016; 10.04.04.0110.000168%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000112%Not Available
Gastrointestinal angiodysplasia24.03.03.007; 07.15.04.0010.000246%Not Available
Intracranial tumour haemorrhage17.08.01.052; 24.07.04.028; 16.32.03.0230.000112%Not Available
Lymphadenopathy mediastinal22.09.03.006; 01.09.01.0250.000112%Not Available
Malignant pleural effusion22.05.04.001; 16.32.03.0140.000224%Not Available
Metastases to bone15.09.03.006; 16.22.02.005--Not Available
Pancreatic atrophy07.18.02.0060.000168%Not Available
Pancreatic carcinoma metastatic16.13.10.003; 07.21.09.0060.000112%Not Available
Pneumothorax spontaneous22.05.02.0070.000112%Not Available
Rectal perforation07.04.01.0040.000112%
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ADReCS-Target
Drug Name ADR Term Target
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